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Glaxo Smith Kline GSK Wavre - LSME Alarm
Wavre,
Belgique
Glaxo Smith Kline GSK Wavre
Act as the Alarm System Subject Matter Expert for GSK Belgium aligning local management and operations with GQP, GES and VSOP requirements. Support all Belgian GSK Vaccines sites regarding alarm definition issues, alarm system performance management and training based on industry best practices. Define rules, coordinate and implement alarm management improvement and remediation strategy and/or projects. Understand and master Quality systems interconnected to alarm (Maintenance, Validation, Calibration, Environmental Monitoring, CSV, Automation, etc.); Manage and monitor the correct application of the quality systems used (SOP, CAPA, eCC, deviation, quality alert, etc.) to ensure readiness for inspections and deploy cross-functional improvement projects.
Your responsibilities:
- You will be content owner for alarm system and fronter during audits/inspections, prepare M/SPU dry runs and lead written response for risks, observations, deviations, improvement initiatives, remediation).
- You will maintain current knowledge and contribute to the definition and/or revision and/or deployment of regulations and guidance, regulatory expectations, QMS and technical standards, innovative technologies, inspection intelligence and industry standards related to alarm system.
- You will own, manage, develop and maintain applicable transversal (site) procedures, tools, training material, templates and other documents (SOPs, WKIs) linked to alarm system. Be consulted for revision of local procedures & documents.
- You will rely on knowledge and expertise to propose and/or develop innovative approaches to drive performance and continuous improvement to alarm system. Set mid-long-term vision and drive implementation of site/local strategy.
- You will monitor alarm system/process effectiveness & performance at local/site level (in place and in use)
- You will collect and analyze data, anticipate and lead issue solving sessions, troubleshooting, drive appropriate remediation/action plans, highlight best practices, drive continuous improvement in alarm management.
- You will escalate risks, gaps, resources, for alarm system to appropriate local/site governance
- You will provide input/give advice and support the MPU/SPU on projects related to alarm system in MPU/SPU. Lead transversal projects related to alarm system.
- You will manage network of local alarm’s SME/SPOCs (via Alarm Management Board), mentor and coach them, encourage good practices sharing and maintain relationship with global (GSME, MSAT,…) and technical experts within the organization (site, Vaccines).
- You will manage and develop competencies and knowledge of all actors in alarm system
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Engineering degree at BSc/MSc level : Electro-mechanical, Mechanical or Automation (Minimum 5 years in the industry in a position in engineering, maintenance, or automation)
- Experience with CMMS, preferably SAP
- Knowledge / experience in the application of quality systems (CAPA, Deviation, Change control)
- Ability to work under pressure, solve challenges, get support and make decisions.
- Easy communication in English, speech and writing
- Must be able to exercise good judgment to set priorities, Results oriented
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Autonomous to manage projects
- A sound understanding of reliability and maintenance engineering and broad knowledge of equipment dominant failures
- Must be able to exercise good judgment in order to set priorities
- Result oriented
- Effective at networking and influencing, good communication skills to engage people in actions, able to adapt to any type of interlocutor (from operators to directors)
*Li-GSK #vaccinessupplychain
Why GSK?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years.
We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose.
For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey.
Join our challenge to get Ahead Together.
Si vous présentez un handicap et si vous avez besoin d' une assistance au cours du processus de sélection, vous pourrez nous informer de l'assistance dont vous avez besoin pour que nous prenions les dispositions nécessaires.
Notre objectif est d'être l’une des entreprises les plus innovantes, les plus performantes et dignes de confiance de l'industrie pharmaceutique. Nous pensons que nous apportons quelque chose d'unique chez GSK et lorsque nous associons nos connaissances, nos expériences et nos styles, l'impact est incroyable. Venez rejoindre notre aventure chez GSK où vous trouverez l'inspiration pour faire au mieux votre travail pour nos patients et pour nos clients. Un endroit où vous pouvez vous recentrer, vous sentir bien et aller de l'avant.
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